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REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System (REPAIR)

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ClinicalTrials.gov Identifier: NCT02703311
Recruitment Status : Terminated (Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.)
First Posted : March 9, 2016
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE March 9, 2016
Results First Submitted Date  ICMJE September 3, 2020
Results First Posted Date  ICMJE November 9, 2020
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. [ Time Frame: 30 days ]
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
Reduction in severity of MR at 30 days of at least one category on a 0-4 scale. [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
  • Change in Distance Walked on 6 Minute Walk Test [ Time Frame: 6 months over Baseline ]
    Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
  • Change in Mitral Regurgitation Severity [ Time Frame: 6, 12, and 24 months over baseline ]
    Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
  • Change in distance walked on 6 minute walk test [ Time Frame: 6 months over Baseline ]
  • Change in Mitral regurgitation severity [ Time Frame: 6, 12, and 24 months over baseline ]
Current Other Pre-specified Outcome Measures
 (submitted: October 16, 2020)
  • Change in Distance Walked on 6 Minute Walk Test [ Time Frame: 12, and 24 months over baseline ]
    Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
  • Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 6, 12, and 24 months over baseline ]
    Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
  • Change in New York Heart Association (NYHA) Class [ Time Frame: 6, 12, and 24 months over baseline ]
    NYHA Class at 6, 12, and 24 months compared to baseline
  • Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 6, 12, and 24 months over baseline ]
    Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
  • Change in Left Ventricular End Systolic Volume (LVESV) [ Time Frame: 6, 12, and 24 months over baselines ]
    Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
  • Number of Participants With Device Success [ Time Frame: Discharge ]
    Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
  • Number of Participants With Patient Success [ Time Frame: 6 and 12 months ]
    Individual patient success (measured at 6 months and 1 year) defined as device success and the following:
    • Discharged from index hospitalization
    • NYHA class improvement by at least 1 level from baseline
  • Number of Days Alive and Out of Hospital [ Time Frame: 12 months ]
    Days alive and out of hospital due to major cardiovascular events at 1 year
  • Freedom From All-cause Mortality and Major Adverse Events (AE) [ Time Frame: 30 days from implant procedure or hospital discharge, whichever is later. ]
    Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
  • Need for Urgent/Emergent Surgical Intervention [ Time Frame: 24 months ]
    Number of patients who undergo urgent/emergent surgical intervention post procedure
Original Other Pre-specified Outcome Measures
 (submitted: March 8, 2016)
  • Change in distance walked on 6 minute walk test [ Time Frame: 12, and 24 months over baseline ]
  • Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 6, 12, and 24 months over baseline ]
  • Change in New York Heart Association (NYHA) Class [ Time Frame: 6, 12, and 24 months over baseline ]
  • Change in left ventricular end diastolic volume (LVEDV) [ Time Frame: 6, 12, and 24 months over baseline ]
  • Change in left ventricular end systolic volume (LVESV) [ Time Frame: 6, 12, and 24 months over baselines ]
  • Device susses [ Time Frame: Discharge ]
    Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
  • Patient success [ Time Frame: 6 and 12 months ]
    Individual patient success (measured at 6 months and 1 year) defined as device success and the following:
    • Discharged from index hospitalization
    • NYHA class improvement by at least 1 level from baseline
  • Number of days alive and out of hospital [ Time Frame: 12 months ]
    Days alive and out of hospital due to major cardiovascular events at 1 year
  • Freedom from all-cause mortality and major adverse events (AE) [ Time Frame: 30 days from implant procedure or hospital discharge, whichever is later. ]
    Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
  • Need for urgent/emergent surgical intervention [ Time Frame: 24 months ]
 
Descriptive Information
Brief Title  ICMJE REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Official Title  ICMJE REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Brief Summary

The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.

Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Insufficiency
  • Cardiac Valve Annuloplasty
  • Mitral Valve Annuloplasty
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Mitral Regurgitation
Intervention  ICMJE Device: Cardioband
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Study Arms  ICMJE Cardioband procedure
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Intervention: Device: Cardioband
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 10, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2016)
50
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years
  2. Severe (3+ to 4+) secondary Mitral Regurgitation
  3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
  4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
  5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
  6. Subject is willing and able to provide informed consent and follow protocol

Exclusion Criteria:

  1. EF < 20%
  2. LVEDD ≥ 70 mm
  3. Heavily calcified annulus or leaflets
  4. Significant CAD requiring revascularization
  5. Active bacterial endocarditis
  6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
  7. Renal insufficiency requiring dialysis
  8. Life expectancy of less than twelve months
  9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
  10. Pulmonary hypertension ≥ 70mmHg at rest
  11. Mitral valve anatomy which may preclude proper device treatment
  12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
  13. Severe liver disease
  14. Patient is pregnant or lactating
  15. Hypersensitivity to Nickel or Chromium
  16. Clinically significant bleeding diathesis or coagulopathy
  17. History of mitral valve repair
  18. TIA or CVA within 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02703311
Other Study ID Numbers  ICMJE CB1-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Edwards Lifesciences
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP